Fetal HypoxiaNCT07827222
Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
An observational study of Fetal Hypoxia and Fetal Distress, run by Assiut University.
Trial summary
Cardiotocography (CTG) is the standard method for monitoring fetal heart rate and uterine contractions during labor to detect signs of fetal hypoxia. However, human CTG interpretation is often subjective and subject to high interobserver variability, even among experienced clinicians. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Hypoxia, Fetal Distress, Low Apgar Score
- How many people
- 415 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Pregnant women admitted in active labor at term (gestational age 37+0 weeks or greater) with singleton pregnancies in cephalic presentation undergoing routine continuous intrapartum cardiotocography (CTG) monitoring at Abutig Specialized Hospital and Women's Health Hospital, Assiut University, Egypt.
Who may be able to join
- Singleton pregnancy
- Gestational age 37+0 weeks or greater
- Cephalic fetal presentation
- Admission to the labor ward in active labor
- Continuous intrapartum cardiotocography (CTG) monitoring
- Availability of an interpretable CTG tracing immediately preceding delivery
- Availability of documented 1-minute and 5-minute Apgar scores
- Written informed consent obtained prior to enrollment
Who cannot join
- Multiple pregnancy
- Major fetal congenital anomalies
- Antepartum stillbirth
- Elective cesarean delivery performed before the onset of labor without an adequate intrapartum CTG tracing
- CTG tracing with inadequate technical quality, including signal loss of 15% or greater
- Missing 5-minute Apgar score
- Technical problems preventing standardized CTG image preparation or interpretation
About this study
Official title: Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography: A Diagnostic Accuracy Study
Cardiotocography (CTG) is the standard method for monitoring fetal heart rate and uterine contractions during labor to detect signs of fetal hypoxia. However, human CTG interpretation is often subjective and subject to high interobserver variability, even among experienced clinicians. Multimodal artificial intelligence (AI) models have emerged as potential diagnostic aids capable of evaluating CTG tracings. This prospective diagnostic accuracy study aims to evaluate the diagnostic performance of Gemini Flash 3.6 in interpreting intrapartum CTG recordings according to the 2015 International Federation of Gynecology and Obstetrics (FIGO) guidelines, and to compare its accuracy directly against independent human expert obstetricians.
Participants include pregnant women admitted in active labor at term with a singleton cephalic pregnancy undergoing continuous CTG monitoring. De-identified digital images of the final 60 minutes of CTG tracing prior to delivery will be independently evaluated by Gemini Flash 3.6 and three expert obstetricians. Each evaluator will classify the tracings into one of three FIGO categories: Normal, Suspicious, or Pathological. All evaluators will be blinded to clinical details, delivery outcomes, and other observers' interpretations.
The primary objective is to assess the diagnostic sensitivity of Gemini Flash 3.6 in identifying neonates with a 5-minute Apgar score less than 7. Secondary objectives include comparing the diagnostic performance of the AI model with that of individual expert obstetricians, measuring interobserver agreement among all raters, and assessing associations with 1-minute Apgar scores and umbilical artery blood gas parameters. The AI model will be used solely as an investigational research tool, and its evaluations will not be available to the clinical team or used to guide patient care.
- Conditions
- Fetal Hypoxia, Fetal Distress, Low Apgar Score, Neonatal Acidemia
- Keywords
- Cardiotocography, Intrapartum Fetal Monitoring, Electronic Fetal Monitoring, FIGO Classification, Artificial Intelligence, Large Language Models, Gemini Flash, Diagnostic Accuracy, Interobserver Agreement, Apgar Score
- Medical subject headings
- Fetal Hypoxia, Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intrapartum CTG Monitoring Cohort | Women with singleton term pregnancies (gestational age ≥ 37 + 0 weeks) in cephalic presentation admitted to the labor ward in active labor who undergo routine continuous intrapartum cardiotocography (CTG) monitoring immediately preceding delivery. De-identified digital CTG tracings from this cohort are independently evaluated by Gemini Flash 3.6 and three expert obstetricians according to the 2015 FIGO consensus guidelines, and validated against neonatal outcomes including 1-minute and 5-minute Apgar scores as well as umbilical artery blood-gas analysis where available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Gemini Flash 3.6 for Identifying Neonates With a 5-Minute Apgar Score Less Than 7
Sensitivity is defined as the percentage of neonates with a confirmed 5-minute Apgar score less than 7 who are correctly identified as having a "Pathological" CTG tracing by Gemini Flash 3.6. Intrapartum CTG tracings from the final 60 minutes of labor immediately preceding delivery are interpreted according to the 2015 FIGO guidelines. For binary diagnostic performance analysis, a "Pathological" CTG represents a positive test result, while "Normal" and "Suspicious" CTGs represent negative test results. Sensitivity is calculated as [True Positives / (True Positives + False Negatives)] * 100 and reported with a 95% confidence interval.
Measured: 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal HypoxiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Ahmed Kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827222
- Sponsor's protocol ID
- Gemini Flash vs Human FIGO CTG
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography: A Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT07827222
- Acronym / sponsor ID
- Gemini Flash vs Human FIGO CTG
- Conditions
- Fetal Hypoxia, Fetal Distress, Low Apgar Score, Neonatal Acidemia
- Keywords
- Cardiotocography, Intrapartum Fetal Monitoring, Electronic Fetal Monitoring, FIGO Classification, Artificial Intelligence, Large Language Models, Gemini Flash, Diagnostic Accuracy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiotocography (CTG) is the standard method for monitoring fetal heart rate and uterine contractions during labor to detect signs of fetal hypoxia. However, human CTG interpretation is often subjective and subject to high interobserver variability, even among experienced clinicians. Multimodal artificial intelligence (AI) models have emerged as potential diagnostic aids capable of evaluating CTG tracings. This prospective diagnostic accuracy study aims to evaluate the diagnostic performance of Gemini Flash 3.6 in interpreting intrapartum CTG recordings according to the 2015 International Federation of Gynecology and Obstetrics (FIGO) guidelines, and to compare its accuracy directly against independent human expert obstetricians.
Participants include pregnant women admitted in active labor at term with a singleton cephalic pregnancy undergoing continuous CTG monitoring. De-identified digital images of the final 60 minutes of CTG tracing prior to delivery will be independently evaluated by Gemini Flash 3.6 and three expert obstetricians. Each evaluator will classify the tracings into one of three FIGO categories: Normal, Suspicious, or Pathological. All evaluators will be blinded to clinical details, delivery outcomes, and other observers' interpretations.
The primary objective is to assess the diagnostic sensitivity of Gemini Flash 3.6 in identifying neonates with a 5-minute Apgar score less than 7. Secondary objectives include comparing the diagnostic performance of the AI model with that of individual expert obstetricians, measuring interobserver agreement among all raters, and assessing associations with 1-minute Apgar scores and umbilical artery blood gas parameters. The AI model will be used solely as an investigational research tool, and its evaluations will not be available to the clinical team or used to guide patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrapartum CTG Monitoring Cohort | – | –Women with singleton term pregnancies (gestational age ≥ 37 + 0 weeks) in cephalic presentation admitted to the labor ward in active labor who undergo routine continuous intrapartum cardiotocography (CTG) monitoring immediately preceding delivery. De-identified digital CTG tracings from this cohort are independently evaluated by Gemini Flash 3.6 and three expert obstetricians according to the 2015 FIGO consensus guidelines, and validated against neonatal outcomes including 1-minute and 5-minute Apgar scores as well as umbilical artery blood-gas analysis where available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant women admitted in active labor at term (gestational age 37+0 weeks or greater) with singleton pregnancies in cephalic presentation undergoing routine continuous intrapartum cardiotocography (CTG) monitoring at Abutig Specialized Hospital and Women's Health Hospital, Assiut University, Egypt.
Key inclusion criteria (8 listed)
- Singleton pregnancy
- Gestational age 37+0 weeks or greater
- Cephalic fetal presentation
- Admission to the labor ward in active labor
- Continuous intrapartum cardiotocography (CTG) monitoring
Key exclusion criteria (7 listed)
- Multiple pregnancy
- Major fetal congenital anomalies
- Antepartum stillbirth
- Elective cesarean delivery performed before the onset of labor without an adequate intrapartum CTG tracing
- CTG tracing with inadequate technical quality, including signal loss of 15% or greater
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of Gemini Flash 3.6 for Identifying Neonates With a 5-Minute Apgar Score Less Than 7
Time frame: 5 minutes after birth
Sensitivity is defined as the percentage of neonates with a confirmed 5-minute Apgar score less than 7 who are correctly identified as having a "Pathological" CTG tracing by Gemini Flash 3.6. Intrapartum CTG tracings from the final 60 minutes of labor immediately preceding delivery are interpreted according to the 2015 FIGO guidelines. For binary diagnostic performance analysis, a "Pathological" CTG represents a positive test result, while "Normal" and "Suspicious" CTGs represent negative test results. Sensitivity is calculated as [True Positives / (True Positives + False Negatives)] * 100 and reported with a 95% confidence interval.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Related trials for Fetal Hypoxia
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Not yet recruitingObservational study
Post Market Clinical Follow-up to Assess the Portable Nitric Oxide Generation and Delivery System (INOwill N200) for the Treatment of Neonatal Hypoxic Respiratory Failure Complicated by Pulmonary Hypertension
Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
Not yet recruitingObservational study
Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment
Neonatal Acidemia and Hypoxia
Recruiting
Maternal Oxygen Supplementation for Intrauterine Resuscitation
Fetal Distress, Fetal Hypoxia
Recruiting
Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
Fetal Hypoxia, Fetal Acidemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Hypoxia and Fetal Distress, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Gemini Flash 3.6 for Identifying Neonates With a 5-Minute Apgar Score Less Than 7 (time frame: 5 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.